BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ RAPID DETECTION OF SARS-COV-2

    MDR report key: 12579022 · Received October 5, 2021

    Report

    Report Number
    1119779-2021-01608
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 7, 2021
    Report Date
    January 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES SEEING 3 LINES ON THE KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MATERIAL # 256082), BATCH NUMBER 1152164 TEST DEVICE, THE ANALYZER SAYS NEGATIVE AND PCR RESULTS WERE POSITIVE. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. AN INVESTIGATION WAS PERFORMED ON THE BATCH NUMBER PROVIDED AND NO RELEVANT ISSUE WAS FOUND. RETENTION SAMPLE TESTING WAS NOT DONE BECAUSE THE MATERIAL WAS EXPIRED. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, EXPIRED MATERIALS WILL NOT BE TESTED. THE BD VERITOR SYSTEM ANALYZER MUST BE USED FOR INTERPRETATION OF ALL TEST RESULTS. OPERATORS SHOULD NOT ATTEMPT TO VISUALLY INTERPRET ASSAY RESULTS DIRECTLY FROM THE BD VERITOR SYSTEM TEST CARTRIDGE. WITH SOME SPECIMENS, UP TO FOUR LINES MAY BE VISIBLE ON THE TEST DEVICE. THE VERITOR ANALYZER WILL APPROPRIATELY INTERPRET THE RESULT. THE ROOT CAUSE WAS TRACED TO USER - FAILURE TO FOLLOW INSTRUCTIONS. A TREND ANALYSIS FOR FALSE NEGATIVE OR DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT# 1152164 WAS NOT FOUND FOR THE REPORTED CATALOG# 256082. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 ON THE BD VERITOR¿ RAPID DETECTION OF SARS-COV-2, 2 FALSE NEGATIVES WERE OBTAINED. PCR CONFIRMATORY TESTING WAS PERFORMED WITH POSITIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALLEGED FALSE POSITIVE; SN (B)(6), LOT# 1152164; 2 SAMPLES. CUSTOMER SAYS THEY CAN SEE 3 LINES ON TEST DEVICE, BUT THE ANALYZER SAYS NEGATIVE." "CAN YOU CONFIRM THIS IS AN ALLEGATION OF A FP? BASES ON CUSTOMER'S DESCRIPTION. IT IS FALSE NEGATIVE." "PCR RESULTS ARE DISCREPANT, PER THE CUSTOMER, WHICH MEANS POSITIVE PCR."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 ON THE BD VERITOR¿ RAPID DETECTION OF SARS-COV-2, 2 FALSE NEGATIVES WERE OBTAINED. PCR CONFIRMATORY TESTING WAS PERFORMED WITH POSITIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALLEGED FALSE POSITIVE; SN (B)(4); LOT# 1152164; 2 SAMPLES. CUSTOMER SAYS THEY CAN SEE 3 LINES ON TEST DEVICE, BUT THE ANALYZER SAYS NEGATIVE." "CAN YOU CONFIRM THIS IS AN ALLEGATION OF A FP? BASES ON CUSTOMER'S DESCRIPTION. IT IS FALSE NEGATIVE." "PCR RESULTS ARE DISCREPANT, PER THE CUSTOMER, WHICH MEANS POSITIVE PCR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474215 BD VERITOR¿ RAPID DETECTION OF SARS-COV-2 CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown